FDA: Daptomycin May Increase Eosinophilic Pneumonia Risk
Agency has requested that manufacturer add information about potential risk to drug's label
FRIDAY, July 30 (HealthDay News) -- The U.S. Food and Drug Administration has requested that the manufacturer of daptomycin (Cubicin) add information to its drug label regarding a possible increased risk of eosinophilic pneumonia in patients receiving the drug.
Cubicin is an intravenous antibiotic approved to treat serious skin infections and septicemia. The FDA conducted a review of post-marketing cases of eosinophilic pneumonia from their Adverse Event Reporting System and reviewed published case reports. The agency identified seven cases of eosinophilic pneumonia between 2004 and 2010 that were most likely linked to Cubicin. The FDA requested that the manufacturer of Cubicin, Cubist Pharmaceuticals, add information about the possible risk of eosinophilic pneumonia to the drug label.
Eosinophilic pneumonia is a rare type of pneumonia characterized by migration of eosinophils into the lung. Symptoms include fever, cough, and difficulty breathing. Physicians are advised to discuss the benefits and risks of Cubicin, including the risk of eosinophilic pneumonia, with each patient and to be aware of the signs and symptoms of the disease, including new or worsening fever, respiratory symptoms, or infiltrates on chest imaging studies.
According to the agency's drug safety communication, "based on FDA's review, there appears to be a temporal association between Cubicin administration and the development of eosinophilic pneumonia. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed."